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PD-1inhibitor
PD-1inhibitor is a PD-1 inhibitor Small molecule drug developed by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. It is currently in Phase 3 development for Various solid tumors and hematologic malignancies (specific indications not publicly detailed for this investigational agent). Also known as: Immunotherapy, PD-1 antibody.
A PD-1 inhibitor blocks the interaction between PD-1 on T cells and its ligands (PD-L1/PD-L2) on tumor cells, releasing immune checkpoint inhibition and allowing T cells to recognize and attack cancer.
A PD-1 inhibitor is a type of small molecule that targets the PD-1 protein to modulate the immune system. It has been studied in various clinical trials, including those for metastatic non-small cell lung cancer, head and neck squamous cell carcinoma, and metastatic pancreatic cancer.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | PD-1inhibitor |
|---|---|
| Also known as | Immunotherapy, PD-1 antibody |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
| Drug class | PD-1 inhibitor |
| Target | PD-1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PD-1 (programmed death receptor 1) is an immune checkpoint that normally suppresses T cell activity to prevent autoimmunity. Tumors exploit this pathway by expressing PD-L1/PD-L2 ligands to evade immune attack. PD-1 inhibitors restore anti-tumor T cell function by blocking this inhibitory signal, enabling the immune system to mount an effective response against cancer cells.
Approved indications
- Various solid tumors and hematologic malignancies (specific indications not publicly detailed for this investigational agent)
Common side effects
- Fatigue
- Immune-related adverse events (irAEs)
- Pneumonitis
- Hepatotoxicity
- Colitis
Key clinical trials
- Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy (PHASE3)
- CD40 Agonist and PD-1 Inhibitor in HNSCC (PHASE1)
- PD-1 Inhibitor Therapy Versus Radiotherapy in MPR Patients With Locally Advanced HNSCC After Neoadjuvant Immunochemotherapy (HNC-SYSU-006) (PHASE2)
- Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma
- Neoadjuvant Sintilimab Plus Chemoradiotherapy for Locally Advanced Adenocarcinoma of Esophagogastric Junction (PHASE2)
- Immunotherapy in Combination With Chemoradiotherapy in Unresectable Locally Advanced Esophageal Cancer (PHASE1, PHASE2)
- PD-1 Inhibitor Therapy Versus Radiotherapy in pCR Patients With Locally Advanced HNSCC After Neoadjuvant Immunochemotherapy (PHASE3)
- A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PD-1inhibitor CI brief — competitive landscape report
- PD-1inhibitor updates RSS · CI watch RSS
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University portfolio CI
Frequently asked questions about PD-1inhibitor
What is PD-1inhibitor?
How does PD-1inhibitor work?
What is PD-1inhibitor used for?
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Is PD-1inhibitor also known as anything else?
What drug class is PD-1inhibitor in?
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What does PD-1inhibitor target?
Related
- Drug class: All PD-1 inhibitor drugs
- Target: All drugs targeting PD-1
- Manufacturer: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Various solid tumors and hematologic malignancies (specific indications not publicly detailed for this investigational agent)
- Also known as: Immunotherapy, PD-1 antibody
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing